Implementing a Stability Program for a Biologic

This Biologic stability webinar will discuss the issues present during design and implementation of stability program for large molecule therapeutics. We will discuss the design and validation of stability indicating methods and expiry dating.

Why Should You Attend:

It is must that drugs delivered to patients maintain established potency and efficacy within specified time windows and hence all drug substances/products require expiration dating. The process of data collection & analysis to support , expiry and self life need to be different for large molecules compared to small molecules as the complexity of large molecule therapeutics allows for a greater potential to lose potency through multiple pathways. This can occur during manufacture, transit, or storage.

This webinar addresses issues present when designing and implementing a stability program for large molecule therapeutics. Key topics will be addressed to provide insight into important issues that should be considered to assure maintenance of potency during shelf life of the product.